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510(k) K913803

INTRALUMINAL ARTERY STRIPPER by Omni-Tract Surgical, Div. Minn. Scientific, Inc. — Product Code DWX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 24, 1992
Date Received
August 26, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stripper, Artery, Intraluminal
Device Class
Class II
Regulation Number
870.4875
Review Panel
CV
Submission Type

Other clearances by Omni-Tract Surgical, Div. Minn. Scientific, Inc.

  • K001339 — MRI FASTSYSTEM RETRACTOR SYSTEM (May 17, 2000)
  • K992583 — MASS (MICRO-ACCESS SPINE SYSTEM) (October 29, 1999)
  • K950214 — ABDOMINAL WALL RETRACTOR (February 6, 1995)

Other clearances for product code DWX

  • K121415 — MOLLRING MULTITASC (September 5, 2012)
  • K032105 — ENDOHELIX ENDARTERECTOMY DEVICE (October 30, 2003)
  • K020925 — CARBODISSECTING ENDOSCOPE (April 29, 2003)
  • K003719 — VASCULAR ARCHITECTS PERISCOPE DEVICE (February 28, 2001)
  • K950813 — MOLLRING CUTTER (July 25, 1995)
  • K933498 — EXTERNAL VEIN STRIPPER (March 23, 1994)
  • K911099 — MEHIGAN-PILLING ANGIOSCOPIC VASCULAR INSTRUM. LINE (June 25, 1991)
  • K904944 — TRANSLUMINAL ENDARTERECTOMY DEVICE (December 17, 1990)
  • K895878 — OLYMPUS VALVULOTOME W/DETACHABLE TIP (January 2, 1990)
  • K894496 — OLYMPUS VALVULOTOME W/FIXED TIP (October 12, 1989)